KELNOR 1/35- ethynodiol diacetate and ethinyl estradiol kit

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

ETHYNODIOL DIACETATE (UNII: 62H10A1236) (ETHYNODIOL - UNII:9E01C36A9S), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Предлага се от:

Physicians Total Care, Inc.

INN (Международно Name):

ETHYNODIOL DIACETATE

Композиция:

ETHYNODIOL DIACETATE 1 mg

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Kelnor™ 28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets, USP) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % of Women Experiencing an Unintended Pregnancy % of Women Continuing Use Method Typical Use† Perfect Use‡ Oral contraceptives should not be used in women who have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular disease, myocardial infarction, or coronary artery disease, or a past histor

Каталог на резюме:

Kelnor™ 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets, USP) are packaged in cartons of three blister card dispensers. Each blister card dispenser contains 21 light yellow, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 14 on the other side and 7 white, round, flat-faced, beveled-edge, unscored placebo tablets, debossed with stylized b on one side and 143 on the other side. Each light yellow tablet contains 1 mg of ethynodiol diacetate and 0.035 mg of ethinyl estradiol. Each white tablet contains inert ingredients. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

KELNOR 1/35 - ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
----------
KELNOR™ 1/35 (28 DAY REGIMEN)
(ETHYNODIOL DIACETATE AND ETHINYL
ESTRADIOL TABLETS, USP)
Revised MAY 2006
11001031
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
KELNOR™ 1/35 (28 DAY REGIMEN) (ethynodiol diacetate and ethinyl
estradiol tablets, USP): Each light
yellow tablet contains 1 mg of ethynodiol diacetate and 35 mcg of
ethinyl estradiol. The inactive
ingredients include anhydrous lactose, D&C yellow no. 10 aluminum
lake, magnesium stearate,
microcrystalline cellulose, polacrilin potassium, and povidone. Each
white tablet is a placebo
containing only inert ingredients as follows: anhydrous lactose,
hypromellose, magnesium stearate, and
microcrystalline cellulose.
The chemical name for ethynodiol diacetate is
19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and
for ethinyl estradiol it is 19-nor-17α-pregna-1, 3, 5
(10)-trien-20-yne-3, 17-diol. The structural
formulas are as follows:
ETHYNODIOL DIACETATE: C
H O MOLECULAR WEIG HT: 384 .51
ETHINYL ESTRADIOL C
H
O MOLECULAR WEIG HT: 296.4 0
CLINICAL PHARMACOLOGY
24
32
4
20
24
2
Combination oral contraceptives act primarily by suppression of
gonadotropins. Although the primary
mechanism of this action is inhibition of ovulation, other alterations
in the genital tract, including
changes in the cervical mucus (which increase the difficulty of sperm
entry into the uterus) and the
endometrium (which may reduce the likelihood of implantation) may also
contribute to contraceptive
effectiveness.
INDICATIONS AND USAGE
KELNOR™ 28 DAY REGIMEN) (ethynodiol diacetate and ethinyl estradiol
tablets, USP) are indicated for
the prevention of pregnancy in women who elect to use oral
contraceptives as a method of
contraception.
Oral contraceptives are highly effective. Table 1 lists the typical
accidental pregnancy rates for users
of combination oral contraceptives and o